Catalog Number

4992307/A

Brand Name

Aspira®

Version/Model Number

00884450394977

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

DWM

Product Code Name

APPARATUS, SUCTION, PATIENT CARE

Public Device Record Key

4d530ec2-58b9-44fd-a43f-5c6b731b6fed

Public Version Date

October 11, 2021

Public Version Number

2

DI Record Publish Date

March 20, 2020

Package DI Number

20884450394971

Quantity per Package

36

Contains DI Package

10884450394974

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-